FDA.reportPublic FDA data

Tamsulosin Hydrochloride

Product NDC
70518-2052
11-digit product format
705182052
Labeler code
70518
Product ID
70518-2052_519fedf6-cddd-0bf1-e063-6394a90a607a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamsulosin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202433
Marketing category
ANDA
Marketing start
2019-04-30
Substance
TAMSULOSIN HYDROCHLORIDE
Active strength
.4 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tamsulosin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMSULOSIN HYDROCHLORIDE.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii11SV1951MR
Rxcui863669

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee39297f-c54b-4394-13fa-e0de7b5b9070Product name420250305
ae349df8-97ce-a639-ed32-50a4cb01b1bdProduct name420200313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2052-0Tamsulosin Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE9017
70518-2052-1Tamsulosin Hydrochloride30 in 1 BLISTER PACKCAPSULE3017
70518-2052-2Tamsulosin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3017
70518-2052-3Tamsulosin Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE3017
70518-2052-4Tamsulosin Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE1417
70518-2052-5Tamsulosin Hydrochloride50 in 1 BOXCAPSULE5017
70518-2052-6Tamsulosin Hydrochloride1 in 1 POUCHCAPSULE117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2052TAMSULOSIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 7 package rows20250327_a608ddc8-fe42-484e-b61f-307c60151138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863669tamsulosin HCl 0.4 MG Oral CapsulePSNa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin hydrochloride 0.4 MG Oral CapsuleSCDa608ddc8-fe42-484e-b61f-307c6015113817
863669tamsulosin HCl 0.4 MG Modified Release Oral CapsuleSYa608ddc8-fe42-484e-b61f-307c6015113817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2052-07051820520090 CAPSULE in 1 BOTTLE, PLASTIC (70518-2052-0) 90 capsule2019-04-300000-00-00NoNoCurrent
70518-2052-17051820520130 CAPSULE in 1 BLISTER PACK (70518-2052-1) 30 capsule2019-06-100000-00-00NoNoCurrent
70518-2052-27051820520230 in 1 BOTTLE, PLASTICHistorical
70518-2052-37051820520330 CAPSULE in 1 BOTTLE, PLASTIC (70518-2052-3) 30 capsule2025-03-24NoNoHistorical
70518-2052-47051820520414 CAPSULE in 1 BOTTLE, PLASTIC (70518-2052-4) 14 capsule2025-10-10NoNoHistorical
70518-2052-57051820520550 POUCH in 1 BOX (70518-2052-5) / 1 CAPSULE in 1 POUCH (70518-2052-6) 50 pouch2026-05-11NoNoHistorical
70518-2052-6705182052061 in 1 POUCHHistorical